BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 7848342 · Received September 5, 2018

    Report

    Report Number
    2517506-2018-00508
    Event Type
    Malfunction
    Date Received
    September 5, 2018
    Date of Event
    August 12, 2018
    Report Date
    October 24, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2517506-2018-00508 (05-SEP-2018). ADDITIONAL INFORMATION (26-SEP-2018): SIEMENS PERSONNEL PERFORMED MAINTENANCE ON THE INSTRUMENT WHICH INVOLVED THE REPLACEMENT OF THE SAMPLE ARM. SIEMENS REVIEWED THE FILTER DATA AND CHEMISTRY DATA. THE REPLACEMENT OF THE SAMPLE ARM HAS POTENTIALLY RESOLVED THIS ISSUE. THE SAMPLE ARM IS RESPONSIBLE FOR MOVING THE SAMPLE FROM THE HM WHEEL TO THE CUVETTE RING. MISALIGNMENT OF THE SAMPLE ARM COULD HAVE CAUSED THE DISCORDANT, FALSELY ELEVATED (CARDIAC TROPONIN-I) LTNI RESULT. SAMPLE INTEGRITY CANNOT BE RULED OUT AT THIS TIME. RESULT CODE AND CONCLUSION CODE WERE UPDATED. THE INSTRUMENT IS OPERATING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CCC SPECIALIST REVIEWED THE INSTRUMENT FILES. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE REVIEWED THE FILTER DATA AND DID NOT FIND ANY DISCORDANT RESULTS FROM (B)(6) 2018. SIEMENS IS INVESTIGATING THE ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN-I (LTNI) RESULT WAS OBTAINED ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED TWICE, RESULTING LOWER. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AS A CORRECT RESULT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED LTNI RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687110 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR